Nickel, compound with Titanium (1:1)

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 30 - September 6, 2013

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Nickel, compound with Titanium (1:1)

EC Number:

610-765-8

Cas Number:

52013-44-2

Molecular formula:

NiTi

IUPAC Name:

Nickel, compound with Titanium (1:1)

Details on test material:

100% Equiatomic NiTi intermetallic compound
Batch 1048

Method

Target gene:

histidine

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Controls

Untreated negative controls:

yes

Remarks:

solvent

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: Sodium azide, 9-AAc, 2NF, MMC, 2AAn, CP

Details on test system and experimental conditions:

One day before use the strains were transferred into 100 ml of Cultural Medium and were incubated at 37°C +/- 1°C for 15-18 hours to obtain fresh cultures in exponential growth so to expose at mutagenic effects an high number of cells.
During the test the bacterial strains were kept in an ice bath to avoid theri vitality reduction.

Two extracts of the test product were obtained under dynamic conditions by immersing the test substance in Saline Solution and in DMSO in order to obtain a surface/volume ratio of 0.2 g/ml and maintained at 37°C +/- 1°C for 72 hours.

Plate without metabolic activation:
0.1 ml of assay sample, 0.1 ml of the bacterial cell suspensions and 0.5 ml of PBS was added to aliquotted top agar (containing biotin and Histidine 0.05 mM) in tube, then briefly stirred and poured into minimal glucose agar plates.
After incubation at 37°C +/- 1°C for 48 hrs the reverted colonies were counted in each plate.
Three replications were performed with the assay sample, negative and positive controls.

Plate with metabolic activation:
0.1 ml of assay sample, 0.1 ml of the bacterial cell suspensions and 0.5 ml of the enzymatic system for metabolism activation was added to aliquotted top agar (containing biotin and Histidine 0.05 mM) in tube, then briefly stirred and poured into minimal glucose agar plates.
After incubation at 37°C +/- 1°C for 48 hrs the reverted colonies were counted in each plate.
Three replications were performed with the assay sample, negative and positive controls.

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Neither reproducibile increase in the number of revertants colonies per plate in any strain with or without metabolic activation system was detected. Besides, the statistical test applied showed no significant difference between the numbers of revertants colonies for assay sample vs. negative control.

The verification of the genetic characteristics showed that the test strains maintained the required genetic properties in both the assay repetitions.

The number of spontaneously reverting colonies in the negative control plates did not exceed the established limits and all the positive controls caused a significant increase of number of reverting colonies.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

On the basis of obtained results, according to Official Journal of the European Union 1272/2008 (CLP) and OECD no.471, the test item proved to be Not Mutagenic for all the test strain, either in the presence or absence of metabolic activation.